Scientific Documentation VI140, Vitamin E Acetate, USP
Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package.
Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300
Ver4.01 20.April.2016
Dear Customer,
Thank you for your interest in Spectrum’s quality products and services.
Spectrum has been proudly serving our scientific community for over 45 years. It is our mission to manufacture and distribute fine chemicals and laboratory products with Quality and delivery you can count on every time.
To accomplish our mission, Spectrum utilizes our sourcing leverage and supplier qualification expertise in offering one of the industry’s most comprehensive line of fine chemical products under one brand, in packaging configurations designed to meet your research and production requirements. Our product grades include: USP, NF, BP, EP, JP, FCC, ACS, KSA, Reagent grade, as well as DEA controlled substances. We operate facilities in the United States on the East Coast, West Coast, as well as in Shanghai, China in order to provide the best logistical support for our customers.
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In the following pages, we have designed and prepared documented scientific information to aid you in your initial qualification or your continual use of our products. Please do not hesitate to contact us if further information or the most up-to-date documentation is desired from any of the covered areas.
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Sincerely,
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20.Apr.2016
VI140, Vitamin E Acetate, USP
Table of Contents
Product Specification
Safety Data Sheet (SDS)
Manufacturer
Manufacturing Process Flowchart
Certification of Quality Mangement System (QMS)
Certification of current Good Manufacturing Practices (cGMP)
Product BSE/TSE Statement
Product Allergen Statement
Product Aflatoxin Statement
General Label Information – Sample Label
Product Certificate of Analysis Sample(s)
General Lot Numbering System Guidance
Stability – Shelf Life Guidance
Kosher Certificate
20.Apr.2016 Specification for Vitamin E Acetate, USP (VI140)
Item Number VI140
Item Vitamin E Acetate, USP
CAS Number 7695-91-2
Molecular Formula C31H52O3 Molecular Weight 472.75 MDL Number Synonyms DL-α-Tocoferil Acetate ; (+/-)-α-Tocopherol Acetate ; DL-a-Tocopheryl Acetate
Test Specification Min Max
ASSAY (C31H52O3) 96.0 - 102.0 % ACIDITY TO PASS TEST IDENTIFICATION TO PASS TEST CERTIFIED KOSHER EXPIRATION DATE MANUFACTURE DATE RESIDUAL SOLVENTS TO PASS TEST
SAFETY DATA SHEET
Preparation Date: 01/16/2015 Revision Date: 1/16/2015 Revision Number: G1 Product identifier
Product code: VI140 Product Name: VITAMIN E ACETATE, USP
Other means of identification Synonyms: DL-alpha-Tocopherol Acetate DL-alphaa-Tocopheryl acetate; dl-Vitamin E acetate; All-rac-alpha-Tocopheryl acetate; Tocopherol Acetate; (+/-)-alpha-Tocopherol acetate; alpha-Tocopherol acetate; alpha-Tocopheryl acetate; 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-, acetate CAS #: 7695-91-2 RTECS # GA8747000 CI#: Not available
Recommended use of the chemical and restrictions on use Recommended use: No information available. Uses advised against No information available
Supplier: Spectrum Chemicals and Laboratory Products, Inc. 14422 South San Pedro St. Gardena, CA 90248 (310) 516-8000 Order Online At: https://www.spectrumchemical.com
Emergency telephone number Chemtrec 1-800-424-9300 Contact Person: Martin LaBenz (West Coast) Contact Person: Ibad Tirmiz (East Coast)
2. HAZARDS IDENTIFICATION
Classification
This chemical is not considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)
Not a dangerous substance or mixture according to the Globally Harmonized System (GHS)
Label elements
Product code: VI140 Product name: VITAMIN E ACETATE, 1 / 11 USP Not classified
Hazards not otherwise classified (HNOC) Not Applicable
Other hazards Not available
3. COMPOSITION/INFORMATION ON INGREDIENTS
Components CAS-No. Weight % Trade Secret Vitamin E Acetate 7695-91-2 100 * 7695-91-2
4. FIRST AID MEASURES
First aid measures General Advice: Poison information centres in each State capital city can provide additional assistance for scheduled poisons (13 1126)
Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothes and shoes. Get medical attention if irritation develops. Consult a physician if necessary.
Eye Contact: Flush eye with water for 15 minutes. Get medical attention if irritation occurs. If symptoms persist, call a physician.
Inhalation: Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to an unconscious person. Consult a physician if necessary.
Most important symptoms and effects, both acute and delayed Symptoms Health injuries are not known or expected under normal use.
Indication of any immediate medical attention and special treatment needed Notes to Physician: Treat symptomatically
Protection of first-aiders First-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose of contaminated clothing and equipment as bio-hazardous waste
5. FIRE-FIGHTING MEASURES
Extinguishing Media
Suitable Extinguishing Media: Carbon dioxide (CO2). Dry chemical. Water spray. Alcohol- resistant foam.
Unsuitable Extinguishing Media: Do not use a solid (straight) water stream as it may scatter and spread fire.
Product code: VI140 Product name: VITAMIN E ACETATE, 2 / 11 USP Specific hazards arising from the chemical
Hazardous Combustion Products: Carbon oxides
Specific hazards: May be combustible at high temperatures. May be ignited by heat, sparks or flames. Container explosion may occur under fire conditions or when heated.
Special Protective Actions for Firefighters
Specific Methods: Water mist may be used to cool closed containers. For larger fires, use water spray or fog. Cool containers with flooding quantities of water until well after fire is out. Dike fire-control water for later disposal; do not scatter the material.
Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear
6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protective equipment and emergency procedures
Personal Precautions: Ensure adequate ventilation. Avoid contact with skin, eyes and clothing. Use personal protective equipment. Remove all sources of ignition.
Environmental precautions Prevent further leakage or spillage if safe to do so. Prevent product from entering drains.
Methods and material for containment and cleaning up
Methods for containment Stop leak if you can do it without risk. Absorb spill with inert material (e.g. vermiculite, dry sand or earth). In case of large spill, dike if needed. Dike far ahead of liquid spill for later disposal.
Methods for cleaning up Use appropriate tools to put the spilled material in a suitable chemical waste disposal container. Clean contaminated surface thoroughly.
7. HANDLING AND STORAGE
Precautions for safe handling
Technical Measures/Precautions: Provide sufficient air exchange and/or exhaust in work rooms. Remove all sources of ignition. Keep away from incompatible materials.
Safe Handling Advice: Wear personal protective equipment. Use only in well-ventilated areas. Avoid contact with skin, eyes and clothing. Keep away from heat and sources of ignition. Do not breathe vapors or spray mist. Do not ingest. When using do not smoke. Handle in accordance with good industrial hygiene and safety practice.
Conditions for safe storage, including any incompatibilities
Technical Measures/Storage Conditions: Protect from light. Sensitive to light. Store in light-resistant containers. Store under nitrogen. Keep container tightly closed in a dry and well-ventilated place. Store at room temperature in the original container. Store away from incompatible materials.
Product code: VI140 Product name: VITAMIN E ACETATE, 3 / 11 USP Incompatible Materials: Acids. Alkalis. Bases. Oxidizing agents.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Control parameters
National occupational exposure limits
United States Components OSHA NIOSH ACGIH AIHA WHEEL None None None None Vitamin E Acetate - 7695-91-2
Canada Components Alberta British Columbia Ontario Quebec None None None None Vitamin E Acetate - 7695-91-2
Australia and Mexico Components Australia Mexico Vitamin E Acetate None None 7695-91-2
Appropriate engineering controls
Engineering measures to reduce exposure: Ensure adequate ventilation. Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors and mist below their respective threshold limit value.
Individual protection measures, such as personal protective equipment
Personal Protective Equipment
Eye protection: Goggles. Safety glasses with side-shields.
Skin and body protection: Long sleeved clothing. Chemical resistant apron. Gloves.
Respiratory protection: Respiratory protection is not necessary for normal handling. Good room ventilation or use of local exhaust (fume hood) is sufficient. Use a vapor respirator under conditions where exposure to the substance is apparent (e.g. generation of high concentrations of mist or vapor, inadequate ventilation, development of respiratory tract irritation), and engineering controls are not feasible. Be sure to use an approved/certified respirator or equivalent. .
Hygiene measures: Avoid contact with skin, eyes and clothing. Wash hands before breaks and immediately after handling the product. When using, do not eat, drink or smoke.
9. PHYSICAL AND CHEMICAL PROPERTIES
Product code: VI140 Product name: VITAMIN E ACETATE, 4 / 11 USP 9. PHYSICAL AND CHEMICAL PROPERTIES Physical state: Appearance: Color: Liquid. Oily. Viscous. Pale Yellow. Amber.
Odor: Taste Formula: Odorless. No information available C31H52O3
Molecular/Formula weight: Flash point (°C): Flashpoint (°C/°F): 472.75 225.5 225.5-257°C/437.9-494.6°F
Flash Point Tested according to: Lower Explosion Limit (%): Upper Explosion Limit (%): Closed cup No information available No information available
Autoignition Temperature (°C/°F): pH: Melting point/range(°C/°F): 320-382°C/608-719.6°F No information available -27.5°C/-17.5°F
Boiling point/range(°C/°F): Decomposition temperature(°C/°F): Specific gravity: 443°C/829.4°F No information available No information available
Density (g/cm3): Bulk density: Vapor pressure @ 20°C (kPa): 0.95-0.98 No information available No information available
Evaporation rate: Vapor density: VOC content (g/L): No information available No information available No information available
Odor threshold (ppm): Partition coefficient Viscosity: No information available (n-octanol/water): No information available 12.25
Miscibility: Solubility: No information available Soluble in Acetone Soluble in diethyl ether Soluble in Chloroform Insoluble in water
10. STABILITY AND REACTIVITY
Reactivity Reactive with acids Reacts with alkalis Reacts with bases Reactive with oxidizing agents
Chemical stability Stability: Stable at normal conditions. Sensitive to light. Exposure to light accelerates decomposition.
Possibility of Hazardous Reactions: Hazardous polymerization does not occur
Conditions to avoid: Heat. Ignition sources. Exposure to light. Incompatible materials.
Incompatible Materials: Acids. Alkalis. Bases. Oxidizing agents.
Hazardous decomposition products: Carbon oxides.
Other Information
Corrosivity: No information available
Special Remarks on Corrosivity: No information available
Product code: VI140 Product name: VITAMIN E ACETATE, 5 / 11 USP 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Principal Routes of Exposure: Eyes. Ingestion. Inhalation. Skin.
Acute Toxicity
Component Information
Vitamin E Acetate - 7695-91-2 LD50/oral/rat = >10000 mg/kg (BASF-test) LD50/oral/mouse = >4000 mg/kg LD50/dermal/rabbit = No information available LD50/dermal/rat = >3000 mg/kg LC50/inhalation/rat = No information available LC50/inhalation/mouse = No infomation available Other LD50 or LC50information = No information available
Product Information
LD50/oral/rat = VALUE- Acute Tox Oral = 10000mg/kg
LD50/oral/mouse = Value - Acute Tox Oral = >4000mg/kg
LD50/dermal/rabbit VALUE-Acute Tox Dermal = No information available
LD50/dermal/rat VALUE -Acute Tox Dermal = >3000mg/kg
LC50/inhalation/rat VALUE-Vapor = No information available VALUE-Gas = No information available VALUE-Dust/Mist = No information available
LC50/Inhalation/mouse VALUE-Vapor = No information available VALUE - Gas = No information available VALUE - Dust/Mist = No information available
Symptoms
Skin Contact: Not likely to cause skin irritation. May cause skin irritation in sensitive individuals.
Eye Contact: Not likely to cause eye irritation.
Inhalation Health injuries are not known or expected under normal use. Ingestion Not expected to be a health hazard for usual industrial handling Health injuries are not known or expected under normal use Vitamin E is usually nontoxic. However, large doses (more than 300 units daily) may rarely cause nausea, diarrhea, intestina/stomach cramps, fatigue, unusal tiredness or weakness, headache, dizziness, blurred vision, rash
Product code: VI140 Product name: VITAMIN E ACETATE, 6 / 11 USP Aspiration hazard No information available
Delayed and immediate effects as well as chronic effects from short and long-term exposure
Chronic Toxicity Ingestion of very high doses of vitamin E (greater than 800 units per day for prolonged periods) have been associated with increased bleeding tendencies in vitamin K deficient people, altered metabolism of hormones (thyroid, pituitary and adrenal), altered immunity, impaired sexual function and may cause blood coagulation abnormalities and thromboembolism in susceptible people
Sensitization: No information available
Mutagenic Effects: No information available
Carcinogenic effects: Not considered carcinogenic
Components ACGIH - IARC NTP OSHA HCS - Australia - Prohibited Australia - Notifiable Carcinogens Carcinogens Carcinogenic Carcinogenic Substances Substances Vitamin E Acetate Not listed Not listed Not listed Not listed Not listed Not listed
Reproductive toxicity No data is available
Reproductive Effects: No information available Developmental Effects: No information available Teratogenic Effects: No information available
Specific Target Organ Toxicity
STOT - single exposure No information available STOT - repeated exposure No information available Target Organs: No information available
12. ECOLOGICAL INFORMATION
Ecotoxicity
Ecotoxicity effects: No data available.
Persistence and degradability: No information available
Bioaccumulative potential: No information available
Mobility: No information available
13. DISPOSAL CONSIDERATIONS
Disposal Methods
Waste from residues / unused products: Waste must be disposed of in accordance with Federal, State and Local regulation.
Product code: VI140 Product name: VITAMIN E ACETATE, 7 / 11 USP Contaminated packaging: Empty containers should be taken for local recycling, recovery or waste disposal
Components RCRA - F Series RCRA - K Series RCRA - P RCRA - U Series Wastes Wastes Wastes Series Wastes Vitamin E Acetate None None None None
14. TRANSPORT INFORMATION
DOT UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: Not applicable Packing Group: None ERG No: No information available Marine Pollutant No data available DOT RQ (lbs): No information available
TDG (Canada) UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available
ADR UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Packing Group: No information available Subsidiary Risk: No information available Classification Code: No information available Description: No information available CEFIC Tremcard No: No information available
IMO / IMDG UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available IMDG Page: No information available Marine Pollutant No information available MFAG: No information available Maximum Quantity: No information available
RID UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available
Product code: VI140 Product name: VITAMIN E ACETATE, 8 / 11 USP 14. TRANSPORT INFORMATION Classification Code: No information available Description: No information available
ICAO UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available
IATA UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available
15. REGULATORY INFORMATION
International Inventories
Components U.S. TSCA KOREA KECL Philippines Japan ENCS CHINA Australia EINECS-No. (PICCS) (AICS) Vitamin E Acetate Present Present KE- Present Present (9)- Present Present Present 231-710-0 10751 487 [39121]
U.S. Regulations
California Prop. 65: Safe Drinking Water and Toxic Enforcement Act of 1986.
Chemicals Known to the State of California to Cause Cancer: This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)
Chemicals Known to the State of California to Cause Reproductive Toxicity: This product does not contain a chemical requiring a warning under California Prop. 65. (See table below)
Components Carcinogen Developmental Toxicity Male Reproductive Female Reproductive Toxicity Toxicity: Vitamin E Acetate Not Listed Not Listed Not Listed Not Listed
CERCLA/SARA
Components CERCLA - Hazardous Section 302 Extremely Section 302 Extremely Section 313 - Section 313 - Reporting Substances and their Hazardous Hazardous Chemical Category de minimis Reportable Quantities Substances and TPQs Substances and RQs Vitamin E Acetate None None None None None
U.S. TSCA
Components TSCA Section 5(a)2 - Chemicals With Significant TSCA 8(d) -Health and Safety Reporting New Use Rules (SNURS) Vitamin E Acetate Not Applicable Not Applicable
Canada
Product code: VI140 Product name: VITAMIN E ACETATE, 9 / 11 USP WHMIS hazard class: Non-controlled
Canada Controlled Products Regulation: This product has been classified according to the hazard criteria of the CPR (Controlled Products Regulation) and the MSDS contains all of the information required by the CPR.
Inventory
Components Canada (DSL) Canada (NDSL) Vitamin E Acetate Present Not Listed
Components CEPA Schedule I - Toxic Substances CEPA - 2010 Greenhouse Gases Subject to Manditory Reporting Vitamin E Acetate Not listed Not listed
EU Classification
R-phrase(s) not determined none
S -phrase(s) none
Components Classification Concentration Limits: Safety Phrases Vitamin E Acetate No information
The product is classified in accordance with Annex VI to Directive 67/548/EEC
Indication of danger: Not dangerous None.
16. OTHER INFORMATION
Product code: VI140 Product name: VITAMIN E ACETATE, 10 / 11 USP 16. OTHER INFORMATION
Preparation Date: 01/16/2015 Revision Date: 1/16/2015 Prepared by: Sonia Owen
Disclaimer: All chemicals may pose unknown hazards and should be used with caution. This Safety Data Sheet (SDS) applies only to the material as packaged. If this product is combined with other materials, deteriorates, or becomes contaminated, it may pose hazards not mentioned in this SDS. The physical properties reported in this SDS are obtained from the literature and do not constitute product specifications. Information contained herein does not constitute a warranty, whether expressed or implied, as to the safety, merchantability or fitness of the goods for a particular purpose. Spectrum Chemicals & Laboratory Products, Inc. assumes no responsibility for results obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No warranty against infringement of any patent, copyright or trademark is made or implied. It shall be the user's responsibility to develop proper methods of handling and personal protection based on the actual conditions of use. While this SDS is based on technical data judged to be reliable, Spectrum assumes no responsibility for the completeness or accuracy of the information contained herein.
End of Safety Data Sheet
Product code: VI140 Product name: VITAMIN E ACETATE, 11 / 11 USP
Manufacturer
Product Covered: VI140, Vitamin E Acetate, USP
Spectrum takes ownership as the manufacturer for the Spectrum product listed above and provides full quality assurance, customer service, and technical product support.
While information concerning the raw material manufacturer of our starting materials is considered proprietary, such information can be made available upon request contingent on demonstration of business volume justification and successful execution of confidential disclosure agreement (CDA).
Requests for disclosure of proprietary raw material manufacturer information may be submitted to the assigned account representative for consideration.
Sincerely,
Alan Wang, MSQA, ASQ CQA Senior Manager, Global Supplier Quality Assurance [email protected]
20.Apr.2016
Manufacturing Process Flowchart Vitamin E Acetate, USP - VI140
Trimethylhydroquinone Isophytol suspension
Tocopherol Water synthesis
Extraction Acetic anhydride / sulfuric acid Vitamin E Acetate Acetic acid synthesis
Solvent evaporation
Distillation
Vitamin E Acetate food / pharma grade oil
Sieving
Drumming
Vitamin E Acetate
Spectrum Chemical Mfg Corp
Corporate Headquarters: West Coast Facility: 769 Jersey Ave. 14422 S. San Pedro St. New Brunswick, NJ 08901 Gardena, CA 90248 732.214.1300 310.516.8000
Certificate of Registration
This is to certify that the quality management system of Spectrum China Ltd.
Building A20, No. 3802, Shengang Road, Songjiang District, Shanghai, China
has been assessed and registered by Intertek as conforming to the requirements of ISO 9001: 2008
The quality management system is applicable to:
Provision of service of purchase, testing and sales for chemical products, repacking of non-hazardous chemical products.
Organization Code: 77762704-8 Certificate Number: 111310001-01 Certificate Issue Date: 17 November 2015 Certificate Expiry Date: 14 September 2018
Authorised Signature: Calin Moldovean – President, Business Assurance Intertek Certification Limited, 10A Victory Park, Victory Road, Derby DE24 8ZF, United Kingdom Intertek Certification Limited is a UKAS accredited body under schedule of accreditation no. 014.
In the issuance of this certificate, Intertek assumes no liability to any party other than to the client, and then only in accordance with the agreed upon Certification Agreement. This certificate’s validity is subject to the organization maintaining their system in accordance with Intertek’s requirements for systems certification. Validity may be confirmed via email at [email protected] or by scanning the code to the right with a smartphone. The annual validity of the certificate can also be checked through the website http://www.cnca.gov.cn of CNCA in China.
The certificate remains the property of Intertek, to whom it must be returned upon request.
March 28, 2016
Certificate of cGMP
Dear Valued Customer:
Spectrum Chemicals and Laboratory Products certify that our USP, NF, FCC, EP, BP, JP, and food grade products are produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.
Spectrum is an FDA registered and inspected drug establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows:
Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824 Spectrum -Shanghai, China: 3006174778
Thank you for your interest with Spectrum products. Please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected] if we may be of further assistance.
Sincerely,
Michelle Weston Quality Assurance Specialist
April 18, 2016
Certificate of cGMP
Dear Valued Customer:
Spectrum Chemicals and Laboratory Products certify that the following product(s) is produced, processed, packaged and held in compliance with current Good Manufacturing Practices (cGMP) in accordance with the applicable parts of 21 CFR, parts 210 and 211 of the Code of Federal Regulations.
Catalog Number Product Name VI140 Vitamin E Acetate, USP
Spectrum is an FDA registered and inspected drug establishment. Our United States Food and Drug Administration (USFDA) Registration numbers are as follows:
Spectrum-Gardena, CA: 2020632 Spectrum-New Brunswick, NJ: 2246824 Spectrum-Shanghai, China: 3006174778
Thank you for your interest with Spectrum products. Please feel free to contact the Quality Assurance department at 310-516-8000 or via email at [email protected] if we may be of further assistance.
Sincerely,
Michelle Weston Quality Assurance Specialist
April 18, 2016
Re: Vitamin E Acetate, USP-VI140
To Whom It May Concern:
Thank you for your interest in Spectrum high quality chemicals.
We at Spectrum Chemical Mfr. Corp. understand the concern regarding Bovine Spongiform Encephalopathy (BSE). Please be assured that the chemical
Vitamin E Acetate, USP-VI140 is BSE/TSE free.
If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected].
Sincerely,
Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp.
This document has been produced electronically and is valid without a signature
April 18, 2016
Re: Vitamin E Acetate, USP- VI140
To Whom It May Concern:
Thank you for your interest in Spectrum high quality chemicals.
We at Spectrum Chemical Mfr. Corp. understand the concern regarding the presence of allergens in raw materials. Please be assured that the following chemical does not contain (Milk; Egg; Fish; Shellfish; Sulfur dioxide and sulfites at concentrations of more than 10 mg/kg or 10 mg/liter expressed as SO2; Lupin; Tree nuts; Mollusks; Wheat; Peanuts; Soy; Cereals containing Gluten; Celery; Mustard; Sesame Seed).
Vitamin E Acetate, USP-VI140
If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected].
Sincerely,
Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp.
This document has been produced electronically and is valid without a signature
April 18, 2016
Re: Vitamin E Acetate, USP-VI140
To Whom It May Concern:
Thank you for your interest in Spectrum high quality chemicals.
We at Spectrum Chemical Mfg. Corp. understand the concern regarding Aflatoxins in raw materials. To the best of our knowledge, the product listed below is not contaminated with Aflatoxins. Aflatoxins are not used in production. The following product does not come in contact with Aflatoxins at any stage of production.
Vitamin E Acetate, USP-VI140
If you have any further questions, please contact Tech Services at (310) 516- 8000 Extension 5471, or by email at [email protected].
Sincerely,
Darlene Dagdag-Lyudmirskiy Technical Services Spectrum Chemical Mfr. Corp.
This document has been produced electronically and is valid without a signature Label Information
The Spectrum label presents technical and safety information in an easily understood format. Our technical specialists stay abreast of the latest requirements of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS), as well as the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA) and other government regulatory agencies in order to ensure compliance, accuracy and concise hazard communication.
C H O K F.W. 472.75 A 31 52 3 C
D F USE CARE: This material has been VI140 20 KG evaluated per GHS/OSHA criteria and Assay ...... 96.0-102.0% is not classified as hazardous. All Vitamin E Acetate MAXIMUM LIMITS chemicals may pose unknown hazards Acidity ...... To pass test and must be used with caution. Use (DL-a-Tocopheryl Acetate) Residual Solvents ...... To pass test personal protection and safe handling E methods consistent with proper U.S.P. LIGHT SENSITIVE: Keep tightly closed in light- H N workplace safety practices. Consult G CAS 7695-91-2 k resistant containers. SDS for additional properties and precautions. If adverse reaction occurs FLUSHED WITH NITROGEN Exp. Date: 03-31-2025 Date: Exp. CAUTION: For manufacturing, processing or seek medical attention. repacking. KEEP FROM CHILDREN Read and understand the label and Safety Data Sheet (SDS) prior to use. M
*49452VI140062233BLA* Chemical Emergency: (800)424-9300 O L J www.SpectrumChemical.com G 11/E1GHS A Lot No. 062233 SPECTRUM CHEMICAL MFG. CORP. Gardena, CA 90248 • New Brunswick, NJ 08901
Label Legend
A Bar Code F Size/Quantity K Empirical Formula, Formula Weight and Technical B GHS Hazard Pictograms G Chemical Abstracts Service Specifications Panel C Warning, Safety Data and Precautionary (CAS) Registry Number L Expiration Information Information H Caution Information D Product Catalog Number M Lot Number I DOT Shipping Information E Item Name, Form, Grade N Kosher Certified by Kosher J Toll-Free 24-Hour Chemical Supervision of America (KSA). O Storage Color Band Emergency Telephone Number
This color-coded band indicates the hazard most likely to be posed by that material under storage conditions. YELLOW: Oxidizer The criteria used to assign band colors have been established by the Storage Code working group of the Society for Chemical Hazard Communication (SCHC). It is recommended that like colors be stored together, RED: Flammable unless otherwise stated, based on the color codes indicated to the right. However, it is the responsibility of GREEN: General Storage the customer to check with their local fire department for possible conflicts with our recommendations when storing hazardous chemicals. BLUE: Health Hazard
WHITE: Corrosive Spectrum Chemical Mfg Corp
Corporate Headquarters: West Coast Facility: 769 Jersey Ave. 14422 S. San Pedro St. New Brunswick, NJ 08901 Gardena, CA 90248 732.214.1300 310.516.8000 Certificate Of Analysis
Item Number VI140 Lot Number 1FB0454
Item Vitamin E Acetate, USP
CAS Number 7695-91-2
Molecular Formula C31H52O3 Molecular Weight 472.75
Test Specification Result min max
ASSAY (C31H52O3) 96.0 - 102.0 % 97.0 % ACIDITY TO PASS TEST PASSES TEST IDENTIFICATION TO PASS TEST PASSES TEST CERTIFIED KOSHER KOSHER EXPIRATION DATE 05-FEB-2018 MANUFACTURE DATE 06-FEB-2015 RESIDUAL SOLVENTS TO PASS TEST . CLASS 2 (SOLVENT) / METHANOL <3000 ppm CLASS 3 (solvent) / HEPTANE <5000 ppm PALE YELLOW APPEARANCE LIQUID
Spectrum Chemical Mfg Corp 14422 South San Pedro Street Gardena 90248 CA
All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia. Certificate Of Analysis
Item Number VI140 Lot Number 2EL0063
Item Vitamin E Acetate, USP
CAS Number 7695-91-2
Molecular Formula C31H52O3 Molecular Weight 472.75
Test Specification Result min max
ASSAY (C31H52O3) 96.0 - 102.0 % 97.0 % ACIDITY TO PASS TEST PASSES TEST IDENTIFICATION TO PASS TEST PASSES TEST CERTIFIED KOSHER KOSHER EXPIRATION DATE 30-SEP-2017 MANUFACTURE DATE 01-OCT-2014 RESIDUAL SOLVENTS TO PASS TEST . CLASS 2 (SOLVENT) / METHANOL <3000 ppm CLASS 3 (solvent) / HEPTANE <5000 ppm PALE YELLOW APPEARANCE LIQUID DATE OF MANUFACTURE 01-OCT-2014
Spectrum Chemical Mfg Corp 755 Jersey Avenue New Brunswick 08901 NJ
All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.
January 26, 2016
RE: Lot Numbering System
Dear Valued Customer:
This letter is to inform you of Spectrum Chemicals and Laboratory Products’ Lot Numbering System. The system is based on an alpha-numerical sequence which provides the month, year and location of production.
The lot numbering system utilized until 2010 is a sequence of six characters, two letters followed by four numbers. The first letter represents the year, for example, Y denotes 2009 and Z denotes 2010. The second letter represents the month and site, for example, A-L denotes January through December at Spectrum’s Gardena, CA facility, while M-X denotes January through December at the New Brunswick, NJ facility. The following four numbers are sequentially assigned. Example: ZI0928 = The 928th material produced in California in September 2010
The lot numbering system utilized for 2011 and forward, is a sequence of seven characters. The first character, a number, represents the production facility:
1 = Gardena, CA Facility 2 = New Brunswick, NJ Facility 3 = China Facility
The second character, a letter, represents the year. For example, A denotes 2011 and B denotes 2012. The third character, a letter, represents the month, with A denoting January and L denoting December. The following four numbers are sequentially assigned.
Example: 2AA0706 = The 706th material produced in New Jersey in January 2011
Thank you for your interest with Spectrum products. Please feel free to contact us at 310-516-8000 or via email at [email protected] if we may be of further assistance.
Sincerely,
Michael Dang Manager, GMP Compliance
Stability – Shelf Life Guidance
Product Covered: VI140, Vitamin E Acetate, USP
Spectrum Chemical’s manufacturing partner has assigned the following shelf life guidance for the product listed above.
The product, VI140, Vitamin E Acetate, USP, is assigned a 36 months shelf life from date of manufacturing. The quality and integrity of the chemical depends on the handling and storage conditions. Please refer to the Safety Data Sheet for proper storage and handling procedures.
Adan R. Hernandez Quality Control Manager
Corporate Headquarters 769 Jersey Avenue New Brunswick, NJ 08901-3605
20.Apr.2016 בס’’ד Feb 08, 2016
The following product(s) prepared by the named company are certied kosher with the stated requirements:
Spectrum Laboratory Products, Inc. S-0032
14422 S. San Pedro Street Product Name Vitamin E Acetate, USP - VI140 Gardena CA 90248 USA Brand Spectrum
UKD-ID KSAV3-P0V6T95
D/P/M P
Symbol Required KSA
Special Conditions This certicate expires on Feb 28, 2017
Rabbi Binyomin Lisbon Kashrus Administrator
Placing the KSA logo on products not listed above constitutes an un-authorized use of the KSA symbol, which is a federally registered trademark.
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Document id: 1069755 P.O.Box 35721, Los Angeles, Ca 90035 - (310) 282-0444 - Fax (310) 282-0505 - Email [email protected] - www.ksakosher.com